[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603053":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":18,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":18,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-4642+AG +Adebrelimab","EXPERIMENTAL","HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned.",[13],"Drug: HRS-4642+AG +Adebrelimab",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Baiyong shen, Dr","CONTACT","008613901943778","shenby@shsmu.edu.cn",[26],{"facility":27,"status":28,"city":29,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":18},"Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine","RECRUITING","Shanghai","China","CN",{"type":33,"coordinates":34},"Point",[35,36],121.45806,31.22222,{"lat":36,"lon":35},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","BAIYONG SHEN","Professor",[43],{"name":44,"class":45},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY","100603053","phase-2-hrs-4642-in-combination-with-gemcitabine-and-albumin-bound-paclitaxel-and-adebrelimab-for-neoadjuvant-and-adjuvant-treatment-of-pancreatic-cancer-100603053",false,"NCT07131514","HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n1. Age: ≥18 and ≤80 years old, male or female;\n2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;\n3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n5. Life expectancy ≥ 12 weeks;\n6. Adequate marrow and organ function;\n7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;\n8. Patients volunteered to participate in this study and signed informed consent;\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor therapy;\n2. the presence of distant metastatic lesions diagnosed by imaging;\n3. Known hypersensitivity to the study drug or any of its components;\n4. previous or concurrent other malignant tumors;\n5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;\n6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;\n7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;\n8. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n9. with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);\n10. with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg\\] test result at screening together with an HBVDNA test value of ≥10,000 copies\u002Fml \\[2000 IU\u002F ml\\]), active hepatitis C (hepatitis C virus antigen \\[HCV-antibodies\\] at screening), or active hepatitis C (hepatitis C virus antitoxin \\[HCVantibodies\\] at screening).antibody \\[HCV-Ab\\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;\n11. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and\u002For lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and\u002For lipase are associated with pancreatic cancer);\n12. Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);\n13. Systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses\n\n    ≤10 mg\u002Fday of prednisone efficacy permitted in the absence of active autoimmune disease\n14. Other situations that the researcher felt should not be included.","ALL","18 Years","80 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer",[64],"Pancreatic Cancer","2026-05-22",{"date":67,"type":68},"2026-05-27","ACTUAL",{"date":70,"type":68},"2025-08-25",{"date":72,"type":58},"2027-12",{"name":5,"class":6},1]